Thayyil Sudhin, Oliveira Vania, Lally Peter J, Swamy Ravi, Bassett Paul, Chandrasekaran Mani, Mondkar Jayashree, Mangalabharathi Sundaram, Benkappa Naveen, Seeralar Arasar, Shahidullah Mohammod, Montaldo Paolo, Herberg Jethro, Manerkar Swati, Kumaraswami Kumutha, Kamalaratnam Chinnathambi, Prakash Vinayagam, Chandramohan Rema, Bandya Prathik, Mannan Mohammod Abdul, Rodrigo Ranmali, Nair Mohandas, Ramji Siddarth, Shankaran Seetha
Centre for Perinatal Neuroscience, Imperial College London, London, UK.
Stats Consultancy, Amersham, Buckinghamshire, UK.
Trials. 2017 Sep 18;18(1):432. doi: 10.1186/s13063-017-2165-3.
Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs.
We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months.
Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection.
ClinicalTrials.gov, NCT02387385 . Registered on 27 February 2015.
在高收入国家，治疗性低温可降低中度或重度新生儿脑病后的死亡和残疾发生率，并在这些地区作为标准疗法使用。然而，在承担了99%疾病负担的低收入和中等收入国家（LMICs），冷却疗法的安全性和有效性仍不明确。我们将研究在LMICs中，全身冷却是否能降低新生儿脑病后18 - 22个月时的死亡或神经残疾发生率。
我们将把408名患有中度或重度新生儿脑病、入住LMIC国家（印度、孟加拉国或斯里兰卡）公共部门新生儿病房的足月儿或近足月儿（年龄≤6小时），随机分配至单纯常规护理组或常规护理加全身冷却组。分配至冷却组的婴儿将使用伺服控制冷却装置将核心体温维持在33.5°C达72小时，随后以每小时0.5°C的速度复温。所有婴儿在入组时将进行详细的感染筛查，并在出生后1 - 2周进行3特斯拉脑磁共振成像和波谱分析。我们的主要终点是18个月时的死亡或中度或重度残疾。
完成后，HELIX将成为新生儿脑病领域最大规模的冷却试验，并将为LMICs中新生儿脑病冷却疗法的安全性和有效性提供明确答案。该试验还将提供关于围产期合并感染对低温神经保护疗效影响的重要数据。
ClinicalTrials.gov，NCT02387385。于2015年2月27日注册。
Zotero 插件